Arthritis of HipNCT03602105
Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement
A study testing Exercise in people with Arthritis of Hip, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Arthritis of Hip
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2019to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.
- Harris Hip Score >60.
- Participants must also be capable in Norwegian and be able to follow exercise sessions.
Who cannot join
- Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty
- Unable to speak and understand the Norwegian language.
- Patients with neurological disorders affecting gait
- Medical contraindications for exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial
Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients.
The investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.
Read the detailed description
More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment.
Given the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking
- Conditions
- Arthritis of Hip
- Being tested
- Exercise
- Keywords
- exercise, prehabilitation, arthritis, quality of life, osteoarthritis, rehabilitation
- Medical subject headings
- Motor Activity, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercises in group and/or individually
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Exercise interventions for 6-12 weeks. Adherence is monitored with day journals Receives: Behavioral: Exercise |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
40 meters Fast-Paced Walk test
Measured: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Secondary outcomes (7)
Change in physical function
30 second sit-to stand test
Measured: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in aerobic capacity
6 min walk test
Measured: 1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
Change in transitional ambulation
Timed-up and go Test (TUG)
Measured: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in pain measured with numeric rating scale (NRS)
NRS - Single score, low score indicates low pain, high score indicated high levels of pain
Measured: Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Length of stay in hospital
Number of days
Measured: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Change in the ability to climb stairs
Stair-climb test. Timed performance from start to stop
Measured: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)
EQ-5D, five dimensions of health scored from 1-5, with 1 being no problem and 2-5 indicate increasing problem (higher score = increase in problem)
Measured: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Mar 2019
- Primary completion30 May 2024 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthritis of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Odd-Einar Svinøy, MSc, Principal investigator, OsloMet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602105
- Sponsor's protocol ID
- 2018/503
- Status last verified
- Nov 2023
- First submitted
- 6 Jun 2018
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Slatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)
Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
PubMed 28808025Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
PubMed 19817509Svinoy OE, Nordbo JV, Pripp AH, Risberg MA, Bergland A, Borgen PO, Hilde G. The effect of prehabilitation for older patients awaiting total hip replacement. A randomized controlled trial with long-term follow up. BMC Musculoskelet Disord. 2025 Mar 6;26(1):227. doi: 10.1186/s12891-025-08468-4.
PubMed 40050814Svinoy OE, Bergland A, Risberg MA, Pripp AH, Hilde G. Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. BMJ Open. 2019 Dec 30;9(12):e031626. doi: 10.1136/bmjopen-2019-031626.
PubMed 31892650
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03602105
- Acronym / sponsor ID
- 2018/503
- Conditions
- Arthritis of Hip
- Keywords
- exercise, prehabilitation, arthritis, quality of life, osteoarthritis, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients.
The investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.
Detailed description
More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment.
Given the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: ExerciseExercise interventions for 6-12 weeks. Adherence is monitored with day journals |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.
- Harris Hip Score >60.
- Participants must also be capable in Norwegian and be able to follow exercise sessions.
Key exclusion criteria (4 listed)
- Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty
- Unable to speak and understand the Norwegian language.
- Patients with neurological disorders affecting gait
- Medical contraindications for exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercises in group and/or individually | Behavioural | Intervention group |
Primary outcome
Change in gait speed
Time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
40 meters Fast-Paced Walk test
7 secondary outcomes
Change in physical function
Time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in aerobic capacity
Time frame: 1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
Change in transitional ambulation
Time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in pain measured with numeric rating scale (NRS)
Time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Length of stay in hospital
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Change in the ability to climb stairs
Time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)
Time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- BackgroundSlatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)
- Background: PubMed 28808025Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
- Background: PubMed 19817509Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
- Derived from this study: PubMed 40050814Svinoy OE, Nordbo JV, Pripp AH, Risberg MA, Bergland A, Borgen PO, Hilde G. The effect of prehabilitation for older patients awaiting total hip replacement. A randomized controlled trial with long-term follow up. BMC Musculoskelet Disord. 2025 Mar 6;26(1):227. doi: 10.1186/s12891-025-08468-4.
- Derived from this study: PubMed 31892650Svinoy OE, Bergland A, Risberg MA, Pripp AH, Hilde G. Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. BMJ Open. 2019 Dec 30;9(12):e031626. doi: 10.1136/bmjopen-2019-031626.
- Individual participant dataSharing planned: Undecided
Related trials for Arthritis of Hip
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odd-Einar Svinøy, MSc principal investigator
OsloMet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Arthritis of Hip, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed (time frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602105, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.